BEUDAMED
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    DIDECO-SHILEY BLOOD REINFUSION BAG

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems

    FDA 510(k)
    FDA Class 2 ·Radiology

    BATTERY CHARGER, 171 PACEMAKER

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code OTP·June 13, 2014

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 12, 2010

    UNKNOWN NECK

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·December 6, 2012

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017